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Model Number PDVXL5 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/01/2024 |
Event Type
Injury
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Event Description
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Patient was implanted with two pdc vivo devices at leave c5-6 and c6-7 on (b)(6)2023.On (b)(6)2024, the surgeon removed one level and converted it to a fusion plate system.No reason for removal was provided, and no patient symptoms are known.
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Manufacturer Narrative
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An mdr is indicated for this complaint.It was reported that a patient was implanted with two pdc vivo devices at leave c5-6 and c6-7 on (b)(6) 2023.On (b)(6)2024, the surgeon removed one level and converted it to a fusion plate system.No reason for removal was provided, and no patient symptoms are known.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels defined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits of surgery outweigh the risks.Device evaluation could not be completed as the implant was returned but could not be located for device evaluation.There were no anomalies associated with the complaint identified during the complaint investigation.The reason for the implant removal is unknown.The submission is 1 of 1 devices involved in this event.
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Search Alerts/Recalls
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